The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Chemtrak Liquid Unassayed Therapeutic Drug Controls.
| Device ID | K936166 |
| 510k Number | K936166 |
| Device Name: | CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-22 |
| Decision Date | 1994-07-13 |